FDA 510(k)

Racz Neurostat RF Generator

K-Number: K232632 · 2024-05-24

Decision Date2024-05-24

Product CodeGXD

Advisory CommitteeNE

DecisionSubstantially Equivalent

Device Summary

Racz Neurostat RF Generator is a medical device manufactured by Epimed International. It received FDA 510(k) clearance on 2024-05-24 under approval number K232632. The device is classified under product code GXD. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Racz Neurostat RF Generator?

Racz Neurostat RF Generator is a medical device that received FDA 510(k) clearance on 2024-05-24. It is manufactured by Epimed International. The 510(k) number is K232632.

When was Racz Neurostat RF Generator approved by the FDA?

Racz Neurostat RF Generator received FDA 510(k) clearance on 2024-05-24, under approval number K232632.

What company makes Racz Neurostat RF Generator?

Racz Neurostat RF Generator is manufactured by Epimed International.

What is the FDA product code for Racz Neurostat RF Generator?

The FDA product code for Racz Neurostat RF Generator is GXD.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.